Mark’s Memo: FDA Updates and News Briefs | 07/26/10

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Mark Mansour
In FDA Regulated Industries

 

Senate Appropriations Committee Funds FDA at Level Requested by President
The Senate Appropriations Committee voted July 15 to approve FDA funding at the President’s requested level, to the dismay of certain stakeholders who had hoped that the agency would be funded at the same level as that recently afforded by the House. The funding includes an additional $2 million for the Office of Generic Drugs and an offset of $5 million, to be determined by the Commissioner. The Committee also expressed its general support for generic drug user fees, for an electronic drug pedigree system that would track drugs as they move through the supply chain, and for guidance from the agency on limiting antibiotics in animal feed.

Mandatory Recall Authority Bill Introduced in Congress
Representative Edolphus Towns has introduced a bill that would give the FDA mandatory recall authority for drugs posing a risk to human health. The bill would permit the agency to order that distribution of a drug stop immediately and be the subject of a recall where the drug posed a risk of serious harm to humans or animals

FDA Withdraws Rule on Pediatric Medical Device Information
The FDA has announced that it has withdrawn a direct final rule that would have required the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The agency decided to withdraw the rule due to significant adverse comment received. More information is available at here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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